BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2082764 · Received April 28, 2011

    Report

    Report Number
    2032227-2011-01079
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH EXTREMELY HIGH BLOOD GLUCOSE LEVELS. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 1200 MG/DL. THE CUSTOMER GOT ON THE PHONE AND WAS VERY INCOHERENT AT THE TIME OF THE CALL. TROUBLESHOOTING WAS PERFORMED, AND FOUND THAT THE CUSTOMER HAD BEEN GETTING MULTIPLE NO DELIVERY ALARMS. THE CUSTOMER ALSO REPORTED BENT CANNULAS AND THE TAPE NOT STICKING WITH THE CURRENT MIO INFUSION SETS. SUGGESTED TRYING DIFFERENT INFUSION SETS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization (B)(4) MIO PARADIGM INSULIN INFUSION SET